Quality of Life After COVID-19 Related Acute respIratory Distress Syndrome Among ICU Survivors Patients in Italy: the ODISSEA Study.

NCT04860687 | Unknown

• 1 other identifier: ODISSEA 1.0
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 8

Brief Summary

Acute respiratory insufficiency is one of the principal causes of intensive care admission for COVID 19 positive patients. This may determine a variable mortality rate ranging from 25-30%. In these patients, many days of non-invasive or invasive mechanical ventilation are needed to correct severe hypoxemia. Mechanical ventilation is not a direct therapy but allows the clinicians to prolong the "time-to-recovery" interval necessary for COVID 19 respiratory insufficiency treatment. Long intensive care stay, mechanical ventilation, the use of steroids and sedatives have an impact on the survivors. Previous studies demonstrated that patients admitted to intensive care with non-COVID acute respiratory distress syndrome had a reduction in the quality of life even up to one year after discharge. The aim of this study is to understand if COVID-19 related acute respiratory distress syndrome has a worse impact on the quality of life one year after discharge when compared with non-COVID-19 acute respiratory distress syndrome.

Conditions

Covid19; Post Traumatic Stress Disorder; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Short Form Health Survey 36

  Evaluate the physical abilities of patients discharged from the intensive care unit after admission for COVID-19 respiratory insufficiency. The scale ranges from 0 to 100, where 0 is the worse value and 100 is the best.

  One year after discharge

Secondary Outcomes (9)

• Impact of Event Scale - Revised (IES-R)

  One year after discharge

• Age

  One year after discharge

• Gender

  One year after discharge

• Scholarship

  One year after discharge

• Marital status

  One year after discharge

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COVID 19 positive patients admitted to the intensive care unit

You may qualify if:

• patients discharged from the intensive care unit after admission for COVID-19 respiratory insufficiency that requested non-invasive or invasive mechanical ventilation

You may not qualify if:

• history of dementia
• history of behavior disorders
• pre-existing tracheostomy
• advanced oncologic disease
• end-stage-organ disease (dialysis, or enlisted for organ transplantation)
• no consent

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (8)

Anesthesia and Intensive Care, Academic Hospital of Catanzaro

Catanzaro, Calabria, Italy

NOT YET RECRUITING

Anesthesia, Intensive Care and Pain Therapy, Academic Hospital "Federico II" of Naples

Naples, Campania, Italy

NOT YET RECRUITING

Anesthesia and Intensive Care, Academic Hospital of Ferrara

Ferrara, Emilia-Romagna, Italy

NOT YET RECRUITING

Anesthesia and Intensive Care 2, Academic Hospital of Parma

Parma, Emilia-Romagna, Italy

NOT YET RECRUITING

Anesthesia and Intensive Care Department, Ravenna Hospital

Ravenna, Emilia-Romagna, Italy

NOT YET RECRUITING

Department of Anesthesia and Intensive Care, Academic Hospital of Udine

Udine, Friuli Venezia Giulia, 33100, Italy

RECRUITING

Anesthesia and Intensive Care 1, Hospital of Trento

Trento, Trentino-Alto Adige, Italy

NOT YET RECRUITING

Anesthesia and Intensive Care 2, Perugia Hospital

Perugia, Umbria, Italy

NOT YET RECRUITING

Related Publications (8)

• Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

  PMID: 32250385 BACKGROUND

• Azoulay E, Thiery G, Chevret S, Moreau D, Darmon M, Bergeron A, Yang K, Meignin V, Ciroldi M, Le Gall JR, Tazi A, Schlemmer B. The prognosis of acute respiratory failure in critically ill cancer patients. Medicine (Baltimore). 2004 Nov;83(6):360-370. doi: 10.1097/01.md.0000145370.63676.fb.

  PMID: 15525848 BACKGROUND

• Thiery G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Levy V, Fieux F, Moreau D, Le Gall JR, Schlemmer B. Outcome of cancer patients considered for intensive care unit admission: a hospital-wide prospective study. J Clin Oncol. 2005 Jul 1;23(19):4406-13. doi: 10.1200/JCO.2005.01.487.

  PMID: 15994150 BACKGROUND

• Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. No abstract available.

  PMID: 32291463 BACKGROUND

• Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15.

  PMID: 32239532 BACKGROUND

• Herridge MS, Cheung AM, Tansey CM, Matte-Martyn A, Diaz-Granados N, Al-Saidi F, Cooper AB, Guest CB, Mazer CD, Mehta S, Stewart TE, Barr A, Cook D, Slutsky AS; Canadian Critical Care Trials Group. One-year outcomes in survivors of the acute respiratory distress syndrome. N Engl J Med. 2003 Feb 20;348(8):683-93. doi: 10.1056/NEJMoa022450.

  PMID: 12594312 BACKGROUND

• Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.

  PMID: 9817120 BACKGROUND

• Vetrugno L, Sala A, Deana C, Meroi F, Grandesso M, Maggiore SM, Isola M, De Martino M, Restaino S, Vizzielli G, Bove T, Driul L. Quality of life 1 year after hospital discharge in unvaccinated pregnant women with COVID-19 respiratory symptoms: a prospective observational study (ODISSEA-PINK study). Front Med (Lausanne). 2023 Sep 6;10:1225648. doi: 10.3389/fmed.2023.1225648. eCollection 2023.

  PMID: 37746068 DERIVED

MeSH Terms

Conditions

COVID-19; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Luigi Vetrugno, MD

CONTACT

+ 39 0432559509; luigi.vetrugno@asufc.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: August 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 7, 2021

Record last verified: 2021-09

Locations

IT (8)